Evaluation of weight-adjusted doses of palonosetron for prevention of postoperative nausea and vomiting in day care laparoscopic gynaecological surgery: A dose ranging, randomised controlled trial

Abstract

Background: Palonosetron 75 mcg is being used for the prevention of postoperative nausea and vomiting. However, weight-adjusted doses in laparoscopic surgery are unevaluated.

Aim: To determine the response to three doses of palonosetron (0.5, 1.0, or 1.5 mcg kg⁻¹) over 72 h in the postoperative period in women undergoing laparoscopic gynaecological procedures.

Design: A randomised dose-response study.

Setting: A tertiary care hospital and research institute in north India from July to December 2014.

Patients: American society of Anesthesiologists physical status I and II women, from 18 to 60 years old, undergoing laparoscopic gynaecological procedures on a day care basis.

Methods: Patients were randomised to receive palonosetron 0.5, 1 and 1.5 mcg kg⁻¹ intravenously before induction of anaesthesia.

Main outcomes measures: The primary outcome was the proportion of patients with a complete response (i.e. who neither vomited nor required additional antiemetic drugs for nausea during the first 72 postoperative hours). The proportion of patients having nausea or emetic episodes and the requirement for rescue antiemetics and analgesics during the 72-h period were recorded as secondary outcomes.

Results: With palonosetron, there was a significant dose-dependent increase (37.5 vs. 67.5 vs. 75%, P < 0.001) in proportion of patients with a complete response during the 72 h. This was associated with a significant dose-dependent decrease in the proportion of patients with nausea (77.5 vs. 47.5 vs. 35%, P < 0.001) and vomiting (47.5 vs. 32.5 vs. 12.5%, P = 0.003).

Conclusion: Following laparoscopic gynaecological surgery, intravenous palonosetron has a dose-dependent prophylactic effect against postoperative nausea and vomiting during the first 72 postoperative hours.

Trial registration: The trial was registered with Clinical trial registry of India(CTRI/2014/09/004987).